PET / CT Imaging and Safety in Patients With Lymphoma Treated With CD19 Car-t Cells

Lymphoma Clinical Trial

Official title:

PET / CT Imaging and Safety of the 68Ga-NOTA-RP25 Molecular Probe in Patients With Lymphoma Who Have Received Prior Therapy Containing CD19 CAR-T Cells

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05176275
• Other study ID #: FirstSoochoowU
• Status: Not yet recruiting
• Phase: N/A
• Start date: January 1, 2022
• Est. completion date: December 1, 2022

Study information

• Verified date: December 2021
• Source: The First Affiliated Hospital of Soochow University
• Contact: Hua Zhang
• Phone: 86 0512 6797 2858
• Email: sdfyy8040[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The proliferation and distribution of CD19 CAR-T cells in lymphoma patients are investigated 68Ga-NOTA-RP25 by PET / CT imaging.

Description:

The purpose of this study is to monitor the proliferation and distribution of CD19 CAR-T cells in lymphoma patients by using a novel specific PET tracer 68Ga-NOTA-RP25 for monitoring the proliferation of CAR-T cells.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 10
• Est. completion date: December 1, 2022
• Est. primary completion date: December 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 1. The subjects voluntarily signed the informed consent form and were able to complete the test according to the protocol requirements; 2. Over 18 years old, male or female;

3. Diagnosed as lymphoma and intended to receive CD19 car-t treatment; 4. ECOG score is 0-1; The estimated survival time shall not be less than 3 months;

Exclusion Criteria:

• 1. Participate in other clinical trials other than CAR-T treatment at the same time or within 28 days. If participating in a non intervention clinical trial, it can be included in this study; 2. Patients with a history of allergy; 3. Patients who cannot tolerant PET / CT imaging; 4. Patients who are using anticoagulant drugs or need to use anticoagulant drugs during the study;

Related Conditions & MeSH terms

• Lymphoma

Intervention

Diagnostic Test:
• 68Ga-NOTA-RP25
The proliferation and distribution of CD19 CAR-T cells in lymphoma patients were investigated by PET / CT after injection of 68Ga-NOTA-RP25

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
The First Affiliated Hospital of Soochow University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	SUV value of radioactive material uptake in the region of interest	According to the PET / CT imaging results of 68Ga-NOTA-RP25 after iterative reconstruction, PMOD software is used to outline the tumor, brain, liver, heart, tumor and other tissues as regions of interest (ROI)	1 month
Secondary	Safety evaluation index	To observe AE/SAE of subjects	1 month